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A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infections

RecruitingPhase 3Ages 18 Years - anyAllAngela HUTTNER
NCT07063095 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to : 1. Test whether the combination of CAZ±AVI and FOS leads to superior clinical outcomes in patients with severe suspected Gram-negative bacterial infection, as demonstrated by a shorter time to normalization of quick Sequential Organ Failure Assessment (qSOFA) parameters and reduction in C-reactive protein (CRP) compared to standard of care (CAZ±AVI alone) 2. to further characterize the safety profile of this combination therapy In the presence of such an infection, standard treatment is to start intravenous antibiotic therapy. Ceftazidime (Fortam®), or ceftazidime-avibactam (Zavicefta®), is a standard antibiotic commonly used for this purpose (for very resistant bacteria, the compound avibactam is included to protect ceftazidime from being broken down by bacteria). Researchers will compare ceftazidime (or ceftazdime-avibactam) plus fosfomycin ve

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adult (≥18 years) 2. Hospitalized with suspected severe Gram-negative bacterial infection 3. Signed informed consent from the patient (or oral consent from a patient with capacity but with physical inability to sign, with signed witness testimony from a person independent of the study team) of from the legal representative if the patient lacks capacity to provide informed consent Exclusion Criteria: 1. Pregnancy or lactation 2. Known contra-indication to CAZ±AVI or FOS 3. Gram-negative directed antibiotic treatment begun \>24 hours before inclusion
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What it tests

  • Ceftazidime± avibactam with fosfomycin
  • Ceftazidime± avibactam with placebo
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Where

1 site
Hôpitaux Universitaires de Genève
Geneva, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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